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Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

Primary Purpose

Delivery Delayed, Mode of Delivery, Post Partum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
duration of initiation of oxytocin
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delivery Delayed focused on measuring primigravida, amniotomy,, immediate oxytocin, delayed oxytocin

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • gestational age between 36+0 to 41+6 weeks
  • singleton pregnancies in cephalic presentation
  • estimated fetal weight between 2.5 - 4.0 kg
  • cervical dilatation of 4 cm with intact membranes
  • normal fetal heart rate trace before artificial rupture of membranes

Exclusion Criteria:

  • Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease)
  • fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early oxytocin Infusion

    Late oxytocin infusion

    Arm Description

    labour augmentation with oxytocin was started early following amniotomy.

    oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.

    Outcomes

    Primary Outcome Measures

    Achieving vaginal delivery
    number of normal vaginal delivery
    Neonatal outcome
    Apgar score

    Secondary Outcome Measures

    Full Information

    First Posted
    December 11, 2019
    Last Updated
    December 12, 2019
    Sponsor
    National University of Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04200599
    Brief Title
    Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women
    Official Title
    Amniotomy and Early Oxytocin Infusion Versus Amniotomy and Delayed Oxytocin Infusion in Nulliparous Women: a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2014 (Actual)
    Primary Completion Date
    January 30, 2016 (Actual)
    Study Completion Date
    March 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National University of Malaysia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In UKM Medical Centre (UKMMC), delayed oxytocin augmentation at two hours following amniotomy is the routine obstetric practice in spontaneous or induced labour with intact membranes. This practice may potentially cause prolonged labour, extended labour room occupancy and increased maternal exhaustion while no additional benefit can be gained. On the other hand, recommendation for early oxytocin augmentation poses a dilemma as the effectiveness and safety of this practice are still in doubt. Given this background, the aim of this study was to compare the effect of early versus delay oxytocin infusion in achieving successful vaginal delivery among the low-risk nulliparous women in UKMMC. Besides, this study also compares the adverse maternal and neonatal outcomes between the two practices.
    Detailed Description
    This was a randomised controlled trial undertaken in the labour room of UKMMC for a period of eighteen months from August 2014 until February 2016. Eligible women who were admitted in spontaneous labour or for induction of labour were recruited. For women who underwent induction of labour, an interval of at least six hours following vaginal prostaglandin before recruitment was mandatory to avoid overlapping effect of prostaglandin and oxytocin. Upon enrolment, each patient was given a study explanation and written consent was obtained. The randomisation sequence, either to the early oxytocin group or the delayed oxytocin group, was generated using the computer randomisation program in block of two. Allocation to either arm of treatment was determined by the sequential opening of sealed numbered envelopes. In the first arm of early oxytocin group, labour augmentation with oxytocin was started early following artificial ruptured of membrane(ARM). In the second arm of delayed oxytocin group, oxytocin augmentation was delayed at two hours after ARM and this practice is currently being used as standard protocol in this hospital to manage women in labour. In both arms,the infusion rate was doubled every 30 minutes to a maximum of 48 mL/h or until four to five moderate contractions per 10 minutes were achieved at which point the infusion rate was maintained. Continuous fetal heart rate monitoring was maintained throughout the intrapartum period. Vaginal examination was performed at four hours after ARM as well as when clinically indicated ie. abnormal cardiotocography (CTG) and maternal desire to bear down. In the presence of abnormal CTG, either fetal blood sampling or expedited delivery was undertaken as per decided by the obstetrician in charge.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delivery Delayed, Mode of Delivery, Post Partum Hemorrhage, Uterine Hyperstimulation
    Keywords
    primigravida, amniotomy,, immediate oxytocin, delayed oxytocin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Early oxytocin Infusion
    Arm Type
    Experimental
    Arm Description
    labour augmentation with oxytocin was started early following amniotomy.
    Arm Title
    Late oxytocin infusion
    Arm Type
    Active Comparator
    Arm Description
    oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.
    Intervention Type
    Other
    Intervention Name(s)
    duration of initiation of oxytocin
    Intervention Description
    mode of delivery
    Primary Outcome Measure Information:
    Title
    Achieving vaginal delivery
    Description
    number of normal vaginal delivery
    Time Frame
    through study completion, an average of 18 months
    Title
    Neonatal outcome
    Description
    Apgar score
    Time Frame
    through study completion, an average of 18 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    all primigravida
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: gestational age between 36+0 to 41+6 weeks singleton pregnancies in cephalic presentation estimated fetal weight between 2.5 - 4.0 kg cervical dilatation of 4 cm with intact membranes normal fetal heart rate trace before artificial rupture of membranes Exclusion Criteria: Women with significant medical (eg. heart disease, pre-eclampsia, diabetes with high dose insulin, retroviral disease) fetal abnormality (eg. fetal growth restriction or small for gestational age < 2.5 kg, suspected macrosomia > 4.0 kg, fetal anomaly)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhammad azrai abu
    Organizational Affiliation
    Department of Obstetrics and Gynecology, UKM Medical Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    17302638
    Citation
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    Citation
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    Citation
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    Citation
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    Citation
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    Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

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